The anti-nausea drug Zofran increases birth defect risks, including heart defects, cleft lip and cleft palate. The FDA has not approved Zofran use for pregnant women. No long-term studies have proven Zofran (generic, Ondansetron) is safe for pregnant mothers. Nevertheless, some doctors continue to prescribe Zofran off-label for severe morning sickness.
Zofran Birth Defect Risks
Though at least one study of Zofran appeared to show no increased risk of birth defects, half the women in that study took the drug only after week ten of their pregnancy. In birth defect drug cases, virtually all of the information now known (the prevailing wisdom) shows the first trimester of pregnancy to be the most vulnerable time for in vitro exposure. That particular study, therefore, looks suspect, even disingenuous by its very design, as if the drug maker is seeing just how closely it can subject the fetus to birth defect risk. Such a study, at best, muddies the waters of whether Zofran is safe for an expectant mother to to take in the first trimester.
Meanwhile, one has to wonder at a medical culture that allows a drug to be prescribed to pregnant women, even late in the first trimester, when that drug has not been proven safe for the unborn child. As with genetically modified food, the FDA essentially green lights an altered food or a new drug and trusts that the corporation that produces it will act with safety foremost in mind. Time and time again that trust has been shown to be misplaced, and hazardous to the health of the people targeted by drug companies as human beings but as “consumers.”